Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,... – Structurally-modified antibody – immunoglobulin – or fragment...
Reexamination Certificate
2005-03-29
2005-03-29
Navarro, Mark (Department: 1645)
Drug, bio-affecting and body treating compositions
Immunoglobulin, antiserum, antibody, or antibody fragment,...
Structurally-modified antibody, immunoglobulin, or fragment...
C424S137100, C424S141100, C530S388100
Reexamination Certificate
active
06872392
ABSTRACT:
Chimeric human antibody expression vectors are constructed by inserting the heavy chain variable region-encoding cDNA and antibody light chain variable region-encoding cDNA isolated from hybridomas producing a mouse or rat monoclonal antibody reacting with the ganglioside GM2respectively into an expression vector which contains the human antibody heavy chain constant region- or human antibody light chain constant region-encoding cDNA. The expression vectors are introduced into animal cells and the transformant thus obtained is cultured to produce a chimeric human antibody reacting with the ganglioside GM2. In contrast to mouse monoclonal antibodies, the chimeric human antibodies of the invention will not cause anti-mouse immunoglobulin antibody production in the patient's body but show a prolonged blood half-life, with a reduced frequency of adverse effects, so that it can be expected to be superior to mouse monoclonal antibodies in the efficacy in the treatment of human cancer, for instance.
REFERENCES:
patent: 5585089 (1996-12-01), Queen et al.
patent: 5830470 (1998-11-01), Nakamura et al.
patent: 5939532 (1999-08-01), Nakamura et al.
patent: 6042828 (2000-03-01), Nakamura et al.
patent: 0 314 161 (1989-05-01), None
patent: 0 533 199 (1993-03-01), None
patent: 9 109 967 (1991-07-01), None
Barker et al., “Effect of a Chimeric Anti-Ganglioside GD2Antibody on Cell-mediaed Lysis Human Neuroblastoma Cells”, Cancer Research, vol. 51, Jan. 1991, pp. 144-149.
Liu et al., “Expression of Mouse: Human Immunoglobulin Heavy-Chain cDNA in Lymphoid Cells”, Gene, vol. 54, No. 1, Jul. 1987, pp. 33-40.
Irie et al., “Human Monoclonal Antibody to Ganglioside GM2 for Melanoma Treatment”, reprinted from The Lancet, pp. 786-787 (1989).
LoBuglio et al., “Mouse/human chimeric monoclonal antibody in man: Kinetics and immune response”, Prod. Natl. Acad. Sci, USA 86:4220-4224 (1989).
Morrison et al., “Chimeric human antibody molecules: Mouse antigen-binding domains with human constant region domains”, Proc. Natl. Acad. Sci. USA 81:6851-6855 (1984).
Jones et al., “Replacing the complementarity-determining regions in a human antibody with those from a mouse”, Nature 231:522-525 (1986).
Hakimi et al., “Reduced Immunogenicity an Improved Pharmacokinetics of Human anti-Tac In Cynomolgus Monkeys”, The Journal of Immunology 147(4): 1352-1359 (1991).
Mueller et al., “Enhancement of Antibody-Dependent Cytotoxicity witha a Chimeric Anti-GD2 Antibody”; The Journal of Immunology, 144(4):1382-1386 (1990).
Bernstein et al., “Monoclonal Antibody Therapy of Mouse Leukemia”, Kenneth R.H. Editor, Monoclonal Antibodies, Plenium Press, New York, pp. 275-291 (1980).
Hakomori, “Aberrant Glycosylation in Cancer Cell Membranes as Focused on Glycolipids: Overview and Perspectives”, Cancer Research 45:2405-2414 (1985).
Natoli et al., A Murine Monoclonal Antibody Detecting N-Acetyl-and-Glycolyl-GM2: Charaterization of Cell Surface Reactivity, Cancer Research 46:4116-4120 (1986).
Tai et al., “Ganglioside GM2 as a human tumor antigen (OFA-I-1)”, Proc. Natl., Acad. Sci. USA 50:5392-5396 (1983).
Miyake et al., Generation of Two Murine Monoclonal Antibodies That Can Discriminate N-Glycol and N-Acetyl Neuraminic Acid residues of GM2Gangliosides, Cancer Research 48: 6154-6160 (1988).
Fredman et al., “A New Ganglioside of the Lactotertraose Series, GaINAC-3'isolM1Detected in Human Meconium”, The Journal of Biological Chemistry 264(12): 12122-12125 (1989).
Miyaji et al., “Expression of human beta-interferon in Namalwa KJM-1 wa adapted to serum-free medium”, Cytotechnology 3: 133-140 (1990).
Kuwana et al., “Expression of Chimeric receptor Composed of Immunoglobulin-Derived V Regions and T-Cell Receptor-Derived C Regions”, Biochemical and Biophysical Research Communications, 149(3):960-968 (1987).
Hamer et al., “SV40 Recombinants Carrying a Functional RNA Splice Junction an Polyadenylation Site from the chromosomal Mouseimg id="CUSTOM-CHARACTER-00001" he="2.46mm" wi="3.56mm" file="US06872392-20050329-P00001.TIF" alt="custom character" img-content="character" img-format="tif" ?majGlobin Gene,” Cell 17:737-747 (1979).
Page et al., “High Level Expression of the Humanized Monoclonal Antibody Campath-1H in Chinese Hamster Ovary Cells”, Bio/Technology 9:64-68 (1991).
Saul et al., “Preliminary Refinement and Structural Analysis of the Fab Fragment from Human Immunoglobulin New at 2.0Åresolution”, The Journal of Biological Chemistry 253(2):585-597 (1978).
Riechmann et al., Reshaping human antibodies for therapy:, Nature 332: 323-327 (1988).
Epp et al., “Crystal and Molecular Structure of a Dimer Composed of the Variable Portions of the Bence-Jones Protein REI”, Eur. J. Biochem. 45:513-524 (1974).
Emery et al., Expert Opinion on Investigational Drugs, vol. 3(3):241-251, Mar. 1994.
Morrison and Ol, Advances in Immunology 44:65-92, 1989.
and Morrison et al, Biotechniques vol. 4: pp 214-221, 1986.
Halcomon in “Monoclonal Antibodies and Functional Cell Lines”, Kennett et al., Ed., Plenum Press 67-100, 1985.
Osband et al, (Immunology Today, vol. 111, No. 6, 1990 pp 193-195).
Harris et al. Tibtech 11:42-44, 1993.
Berek et al; (Cell; vol. 67 pp 1121-1129).
Hanai Nobuo
Hasegawa Mamoru
Koike Masamichi
Kuwana Yoshihisa
Nakamura Kazuyasu
Kyowa Hakko Kogyo Co. Ltd.
Navarro Mark
Nixon & Vanderhye P.C.
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